Welcome to the Big Molecule Watch!
Big Molecule Watch will be posting updates and analyses on regulatory issues, litigation, legislation, and other news in the ever-developing world of biosimilars. The editors of this blog have collectively been watching and engaging with the world of biosimilars (“big molecules”) since before the inception of the biosimilar industry in the U.S., and we’re excited to share the observations of our active watch on this new forum.
If you’re looking for a primer on biologics, check out our background post
introducing the world of biologics, biosimilars, and the Biologics Price Competition and Innovation Act (“BPCIA”).
We’ve also collected (and will continue to update) some reference documents that might be of interest to visitors of this blog—you can find them under the “Links” section to the right of this page.
Today, AbbVie announced
that the F.D.A. approved the inclusion of moderate to severe fingernail psoriasis data in the HUMIRA® (adalimumab) prescribing information for patients with moderate to severe chronic plaque psoriasis. Fingernail psoriasis affects half […]
As we have previously reported
, various amicus briefs have been submitted in Sandoz v. Amgen. On March 17, 11 professors submitted an amicus brief
in support of Amgen. The 11 professors “teach and write […]
Korean Biomedical Review
is reporting that Alteogen will transfer technology related to its ALT-L2, a biosimilar of Herceptin, to Qilu Pharmaceutical of China. According to the article, Alteogen and Qilu will “jointly complete the […]
today that it has approved Genentech’s Ocrevus® (ocrelizumab) for the treatment of adults with relapsing forms of multiple sclerosis and primary progressive multiple sclerosis (“PPMS”). Ocrevus is the first drug approved by the […]
Sanofi and Regeneron announced
yesterday that their Dupixent® (dupilumab) product has received FDA approval for the treatment of adults with moderate-to-severe atopic dermatitis (AD) whose disease is not adequately controlled with topical prescription therapies, or […]
As we previously reported
, a number of amici curiae have submitted briefs in support of each party in Sandoz v. Amgen. On March 17, Biotechnology Innovation Organization (“BIO”), a trade association representing various members […]
Celltrion has filed two additional petitions for inter partes review of Genentech patents related to trastuzumab: IPR2017-01139
, challenging U.S. Patent 6,627,196, and IPR2017-01140
, challenging U.S. Patent 7,371,379. According to the Petitions, the patents […]
As we posted here
, and here
, various amicus briefs have been submitted in Sandoz v. Amgen
. Last week, Janssen Biotech, Inc. submitted an amicus brief
in support of Amgen. Janssen’s brief emphasizes […]
This week Sanofi-Aventis and Regeneron Pharmaceuticals took aim at Amgen’s U.S. Patent No. 8,679,487 on two fronts, filing a declaratory judgment action in district court and a petition for inter partes review in the U.S. Patent & […]
yesterday that the European Commission (EC) has granted marketing authorization for AMGEVITA (biosimilar adalimumab) in all available indications, including certain adult and pediatric inflammatory diseases. AMGEVITA is Amgen’s first biosimilar approved by the EC. […]